MA-ABIOMED
10.1.2022 14:04:04 CET | Business Wire | Press release
Regulators in three countries have granted approvals to Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy for sustainable growth with new products, new indications and new geographies. In the United States, the Food and Drug Administration (FDA) has granted an Early Feasibility Study (EFS) Investigational Device Exemption (IDE) to Impella BTR (Bridge-to-Recovery). In Asia, Impella 5.5 with SmartAssist has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical Device Division (MDD).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220110005312/en/
Impella 5.5 with SmartAssist is a game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, fully unloading heart pump designed by and for heart surgeons with direct or axillary insertion. It received FDA post-market approval (PMA) two years ago. Since then, it has been used to treat more than 4,000 US patients for indications that include AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50%. Impella 5.5 with SmartAssist patients have a 74% survival to explant, with 59% of surviving patients achieving native heart recovery.
In Japan, Impella 5.5 with SmartAssist is now indicated for use in the treatment of drug-resistant acute heart failure attributable to causes such as cardiogenic shock. The first Impella 5.5 with SmartAssist patient in Japan is expected to be treated in the coming months.
“The Japanese market is ideal for Impella 5.5 with SmartAssist because the technology provides minimally invasive, longer-term unloading support, enabling native heart recovery in a country that is more resistant to invasive sternotomies and heart transplants,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.
In the United States, the FDA has approved the Impella BTR early feasibility IDE study, clearing the way for the first patient in the world to be treated with Impella BTR. Impella BTR is a percutaneous heart pump, with greater than six liters of blood flow per minute. It is designed to be much less invasive than current LVADs.
The vision of the Impella BTR development program is to provide a patient with home discharge and up to one year of full hemodynamic support. In the early feasibility study, ten patients will be enrolled at up to five hospitals and supported by Impella BTR for up to 28 days. The first Impella BTR patient is expected to be treated in March or April this year.
“The FDA’s approval is a first step toward making this longer-term minimally invasive forward flow smart heart pump a reality for patients with chronic heart failure,” said Minogue.
Impella BTR is an investigational device, limited by federal law to investigational use only.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are US FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are US FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
Impella BTR® is an investigational device, limited by federal law to investigational use only.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com .
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220110005312/en/
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 13:00:00 CEST | Press release
Transaction accelerates Mobix Labs’ global aerial intelligence strategy and National Security Matters Initiative Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performanc
Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 13:00:00 CEST | Press release
Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP)
SLB Announces Second-Quarter 2026 Results24.7.2026 12:50:00 CEST | Press release
Revenue of $8.97 billion increased 3% sequentially and 5% year on year GAAP EPS of $0.52 increased 4% sequentially and decreased 30% year on year EPS, excluding charges and credits, of $0.55 increased 6% sequentially and decreased 26% year on year Net income attributable to SLB of $786 million increased 5% sequentially and decreased 22% year on year Adjusted EBITDA of $1.90 billion increased 7% sequentially and decreased 7% year on year Cash flow from operations was $1.36 billion and free cash flow was $716 million Board approved quarterly cash dividend of $0.295 per share SLB (NYSE: SLB) today announced results for the second-quarter 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722694386/en/ The exterior of the SLB headquarters in Houston, Texas.Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2026Mar. 31, 2026Jun. 30, 2025SequentialYear-on-yearRevenue $8,972 $8
NIQ Expands GenAI Capabilities Across gfknewron, Turning Trusted Intelligence into Decisions Faster24.7.2026 12:30:00 CEST | Press release
New capabilities help businesses uncover trends faster, simplify complex analysis, and accelerate confident decision-making NIQ (NYSE: NIQ), a leader in consumer intelligence, today announced the expansion of AI-powered Smart Insights across its gfknewron® platform. By bringing together markets and categories into a single view, gfknewron enables businesses to transform complex market, consumer and supply chain data into clear, actionable intelligence quickly. The latest enhancements help users identify trends, opportunities and performance drivers more quickly, reducing the time required to analyze large datasets and accelerating confident decision-making across teams. As brands and retailers face growing pressure to respond quickly to changing consumer behavior and market dynamics, the ability to unlock meaningful insights from increasingly rich datasets has become a significant competitive advantage. As AI is only as effective as the intelligence behind it, Smart Insights helps busi
Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 10:05:00 CEST | Press release
The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200 MM/A) radars to protect the Romanian airspace. This government-to-government agreement underlines the high level of partnership between France and Romania, within the framework of the European Union’s SAFE funding programme, in order to bolster Europe’s defence capabilities. The GM200 MM/A is part of Thales’ proven Ground Master radar family, which has already been deployed in over 40 countries, including now in Romania. In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-governm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom